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FDA 510(k)

URIHESIVE SYS MALE EXTERNAL CATHETER

K-Number: K842397 · 1984-08-08

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1984-08-08
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URIHESIVE SYS MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1984-08-08 under 510(k) number K842397. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIHESIVE SYS MALE EXTERNAL CATHETER?

URIHESIVE SYS MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1984-08-08. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K842397.

When did URIHESIVE SYS MALE EXTERNAL CATHETER receive FDA 510(k) clearance?

URIHESIVE SYS MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1984-08-08, under 510(k) number K842397.

Who is the listed applicant for URIHESIVE SYS MALE EXTERNAL CATHETER?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIHESIVE SYS MALE EXTERNAL CATHETER?

The FDA product code for URIHESIVE SYS MALE EXTERNAL CATHETER is KNX.

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: KNX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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